They Are Still Using the Transvaginal mesh, Despite Warnings

Despite all the horror stories the transvaginal mesh still has FDA approval as a moderate risk device and may be used in surgeries to treat pelvic organ prolapsed and urinary stress incontinence.

There are continued discussions and debates between Doctors, manufacturers,Lawyers and victims. The FDA has not taken any further action to limit the use of transvaginal mesh. September 11th a panel of FDA outside advisors met to discuss whether transvaginal mesh was safe and effective.Johnson & Johnson and other makers of vaginal mesh have reportedly told the FDA that they agree on the need for more safety studies and the need for labeling changes to warn patients of the potential risks. Manufacturers argued that the transvaginal mesh should not be classified as high risk. The FDA released summaries from the advisory panel’s hearings. The panel advised the FDA to reclassifying transvaginal mesh products and require the manufacturers to prove the safety and effectiveness of their products. The FDA typically, but not always, follows the advice of its outside panels.

In the meantime, some surgeon groups are recommending that the use of transvaginal mesh be limited and used only by well trained doctors on carefully chosen patients. There have been some discussions of more advanced Doctor training.

While the arguments by both sides are not surprising, they do draw attention to the competing interests and arguments presented to the FDA. So far, the FDA has not recalled transvaginal mesh products. However, manufacturers of transvaginal mesh devices such as Johnson & Johnson and C.R. Bard are facing hundreds of lawsuits over the alleged side effects of these devices.

While the arguments by both sides are not surprising, they do draw attention to the competing interests and arguments presented to the FDA. So far, the FDA has not recalled transvaginal mesh products. However, manufacturers of transvaginal mesh devices such as Johnson & Johnson and C.R. Bard are facing hundreds of lawsuits over the alleged side effects of these devices.